Detailed Office Action
The communication dated 4/29/2026 has been entered and fully considered. Claim 9 is cancelled. Claim 8 is withdrawn from examination. Claims 1-8 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-7) in the reply filed on 4/29/2026 is acknowledged. The traversal is on the ground(s) that the cited prior art of BURNSIDE fails to disclose each and every technical feature of the medical device of the subject application. This is not found persuasive because describing every technical feature of the medical device (recited or not recited in the claims) is not the standard to determine the unity of invention or lack thereof. The Examiner is required to identify shared technical features (not all technical features) of the two groups of the inventions and show that these shared technical features are not special since they are disclosed by the cited prior art (emphasis added by the Examiner). In the restriction requirement of 1/30/2026, the Examiner showed that BURNSIDE discloses these shared technical features. The Applicant has not provided a specific argument as to the Examiner’s potential error(s). The requirement is still deemed proper and is therefore made FINAL. Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim.
Claim Objections
Claims 4 and 7 are objected to because of the following informalities:
Claim 4, last line: replace “after crimping the fibrous tubular conduit to the balloon catheter annealing of the fibrous tubular conduit is continued” with “after crimping the fibrous tubular conduit onto the balloon catheter, annealing of the fibrous tubular conduit is continued”, for a better recitation of the limitation.
Claim 7, last line: replace “the balloon” with “the balloon catheter” to be consistent with earlier limitations. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2, in line 5, recites the limitation of “a fibrous tubular conduit”. However, this limitation is already recited in line 4 of the same claim. As such it is not clear that the line 5 limitation is the same as the line 4 limitation or a different one. For the purpose of examination, the Examiner interprets these two limitations as the same and in line 5 replaces “providing a fibrous tubular conduit having a similar or slightly larger inner diameter” with “wherein the fibrous tubular conduit having a similar or slightly larger inner diameter”.
Claim 2 recites the limitation "the deflated and folded balloon catheter" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the balloon catheter" (two occurrences) in its last line. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the Examiner replaces the dependency of claim 7 from claim 1 to claim 2 where this limitation is already recited.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, and 6 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by BURNSIDE (US-2012/0029614), hereinafter BURNSIDE. Note that the italicized text below are the instant claims.
Regarding claim 1, BURNSIDE discloses A method of making a medical device comprising: providing a fibrous structure; and annealing said fibrous structure {[abstract], [0002], [0006] note the filament structure is the fibrous structure, [0014], [0017] note annealing}.
Regarding claim 3, BURNSIDE discloses wherein the method comprises the following further steps: providing as fibrous structure a fibrous tubular conduit made of a polymer {[0015] note tubular form or tubular conduit, note use of polymers}; and
positioning the fibrous tubular conduit on a fixed inner carrier of similar or smaller sized outer diameter compared to inner diameter of the fibrous tubular conduit; and constraining the fibrous tubular conduit on that fixed inner carrier by exposing the fibrous tubular conduit to a heat treatment below its melt transition temperature {[0017] note mandrel is the fixed inner carrier and disposing is the constraining, note heat treatment or annealing, note annealing between the two temperatures that indicates lower than melting temperature, [0064] note the smaller diameter of the mandrel or fixed inner carrier}.
Regarding claim 6, BURNSIDE discloses wherein the method comprises the following further step(s): the fibrous structure is exposed to heat by at least one of a convection through a gas, liquid or solid medium {[0133] note recirculating air oven that indicates convection by a gas}.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SANDERS (US-2019/0008664), hereinafter SANDERS.
Regarding claim 1, SANDERS discloses A method of making a medical device comprising: providing a fibrous structure; and annealing said fibrous structure {[abstract], [0061] note annealing}.
Regarding claim 2, SANDERS discloses wherein the method comprises the following further steps: providing a fibrous tubular conduit made of a polymer {[0006] note tubular structure} and;
wherein the fibrous tubular conduit having a similar or slightly larger inner diameter compared to the crossing profile of a deflated and folded balloon catheter; positioning the fibrous tubular conduit over that balloon catheter; and crimping the fibrous tubular conduit onto that balloon catheter by exposing the fibrous tubular conduit to a heat treatment below its melt transition temperature {[0080]-[0081] note mounting over a balloon and annealing, note after annealing the balloon is expanded, thus mounting is over a deflated balloon thus tubular structure has larger diameter than the deflated balloon, note crimping, note annealing is heat treatment, [0061] note heating above Tg that indicates melting temperature is not reached since the structure melts and losses its integrity}.
Regarding claim 3, SANDERS discloses wherein the method comprises the following further steps: providing as fibrous structure a fibrous tubular conduit made of a polymer; and positioning the fibrous tubular conduit on a fixed inner carrier of similar or smaller sized outer diameter compared to inner diameter of the fibrous tubular conduit; and constraining the fibrous tubular conduit on that fixed inner carrier by exposing the fibrous tubular conduit to a heat treatment below its melt transition temperature {see claim 2 above, since this claim is similar to claim 2, in this claim, the deflated balloon discussed under claim 2 reads on the limitation of fixed inner carrier}.
Regarding claim 4, SANDERS discloses wherein the method comprises the following further step: after crimping the fibrous tubular conduit onto the balloon catheter annealing of the fibrous tubular conduit is continued {[0080]-[0081] note that immediately at the start of annealing crimping occurs and further annealing continues, [0103] note additional annealing, [0061] note maintaining annealing for period of time}.
Regarding claim 5, SANDERS discloses wherein the method comprises the following further step(s): the fibrous structure is exposed to cycles with different temperatures, durations and repetitions of cooling and heating or any combination thereof {[0061]}.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over SANDERS in view of BURNSIDE.
Regarding claim 6, SANDERS discloses all the limitations of claim 1 as discussed above. SANDERS, however, is silent on the method of heating or annealing the fibrous structure. Therefore, an artisan would have bene motivated to look to prior art to determine an appropriate method for heating or annealing.
In the same field of endeavor that is related to annealing fibrous structure or stent, BURNSIDE discloses wherein the method comprises the following further step(s): the fibrous structure is exposed to heat by at least one of a convection through a gas, liquid or solid medium {[0133] note recirculating air oven that indicates convection by a gas}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have incorporated the teaching of BURNSIDE in the method of SANDERS and have performed the annealing step with air convection.
As shown by BURNSIDE, this method of heating can achieve a proper annealing as shown in Examples 1-15 {[0144]-[0158]}.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over SANDERS in view of in view of GALE (US-2005/0119720), hereinafter GALE, as evidenced by DECLERCK (US-2013/0273685), hereinafter DECLERCK.
Regarding claim 7, SANDERS discloses all the limitations of claims 1-2 as discussed above. SANDERS, however, is silent on the method of heating or annealing the fibrous structure. Therefore, an artisan would have been motivated to look to prior art to determine an appropriate method for heating or annealing.
In the same field of endeavor that is related to annealing fibrous structure or stent, GALE discloses , wherein the method comprises the following further step(s):
the fibrous structure is heated by infrared, which wavelength is chosen not to directly heat the material of the balloon and/or other parts of the balloon catheter {[0006]/[0049]}.
At the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have incorporated the teachings of GALE in the method of SANDERS and have performed the annealing step with infrared radiation. As shown by GALE, this method of heating can achieve a proper annealing as shown in its examples.
Regarding the limitation of chosen wavelength, GALE discloses that the damage to the balloon should be avoided {[0006]}. Therefore, and at the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to have chosen the wavelength such that only the stent can be heated and not the balloon so that damage to the balloon could be avoided. The Examiner notes that as evidenced by DECLERCK, the choice of infrared wavelength is a variable that be selected based on the material that needs to be heated {[0045]}, thus, it would have been within the skill of an artisan to have selected the wavelength so that only the stent, and not the balloon would have been heated and annealed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to S. BEHROOZ GHORISHI whose telephone number is (571)272-1373. The examiner can normally be reached Mon-(alt Fri) 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abbas Rashid can be reached at 571-270-7457. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S. BEHROOZ GHORISHI/ Primary Examiner, Art Unit 1748
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